The Modernization of Cosmetics Regulation Act (MoCRA), enacted in 2022, represents the most significant update to U.S. cosmetic regulations in more than 80 years. This law gives the Food and Drug Administration (FDA) expanded authority to oversee cosmetic products sold in the United States. Unlike previous frameworks that relied heavily on voluntary actions, MoCRA introduces mandatory requirements for cosmetic manufacturers, distributors, and importers. Companies must now follow strict guidelines to ensure that their products meet safety, labeling, and reporting standards, reshaping how the cosmetic industry operates domestically and internationally.
Facility Registration and Product Listing
One of the key requirements of MoCRA compliance is the registration of manufacturing facilities and listing of cosmetic products. All facilities involved in producing cosmetics for the U.S. market must register with the FDA and renew their registration biennially. Additionally, each marketed cosmetic must be listed with the agency, including details such as product ingredients, formulation, and responsible party information. This level of transparency is intended to strengthen oversight, allow faster response to safety concerns, and provide consumers with increased confidence in the products they use daily.
Safety Substantiation and Documentation
MoCRA also requires cosmetic companies to maintain adequate safety substantiation for their products. This means that every cosmetic marketed in the U.S. must be supported by reliable scientific evidence demonstrating its safety under recommended usage conditions. Companies must keep detailed records of safety studies, ingredient assessments, and toxicological evaluations. Failure to provide this documentation upon request by the FDA can lead to enforcement actions, including product recalls or legal penalties. For businesses, this requirement emphasizes the importance of rigorous research and a well-documented quality management system.
Labeling and Adverse Event Reporting
Another critical component of MoCRA compliance is updated FDA MoCRA compliance labeling and mandatory reporting of adverse events. Cosmetic labels must now include contact information that allows consumers to report adverse reactions. Furthermore, responsible parties must report serious adverse events, such as hospitalizations or life-threatening reactions, to the FDA within 15 business days. This reporting system creates a stronger link between consumers, companies, and regulators, enabling the early detection of harmful trends and faster regulatory interventions. Proper labeling also ensures that consumers are fully informed about product ingredients and safe usage.
Preparing Businesses for Regulatory Change
For cosmetic companies, achieving MoCRA compliance requires strategic planning and significant operational adjustments. Businesses must review their supply chains, enhance product testing procedures, and implement robust recordkeeping systems. Many companies are seeking legal and regulatory guidance to ensure they meet all obligations before enforcement deadlines. Compliance not only avoids legal risks but also enhances brand credibility in an increasingly health-conscious market. By aligning with MoCRA, cosmetic businesses demonstrate their commitment to safety, transparency, and consumer trust, positioning themselves for long-term success in a regulated environment.
